Double-blind, double-dummy, multi-center, randomized parallel group trial to demonstrate therapeutic equivalence of Salmeterol/Fluticasone MDI HEXAL (25 µg/50 µg per actuation) versus SeretideTM 50 (25 µg/50 µg per actuation) over a period of 12 weeks in pediatric patients aged 4-11 years with persistent moderate asthma
- Conditions
- Persistent, moderate asthmaMedDRA version: 9.1Level: LLTClassification code 10003555Term: Asthma bronchial
- Registration Number
- EUCTR2007-000135-26-LT
- Lead Sponsor
- Hexal AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
At Visit -1:
1. Male or female children aged 4 to 11 years
2. Written informed consent signed according to local requirements by one or by both patient’s parent(s) or legal representative prior to any protocol specific procedures
3. Medical history of persistent moderate asthma (according to GINA) of at least 6 months duration
4. Regular use of ICS or ICS plus LABA over the 6 months immediately prior to Visit -1
5. Regular treatment with
•medium- to high-dose ICS or medium-dose ICS plus LABA (children <5 years)
•high-dose ICS or low- to medium-dose ICS plus LABA (children >=5 years)
within the 4 weeks immediately prior to Visit -1
6. Ability to perform spirometric maneuvers with a forced expiratory time of at least 1 second
7. Patients aged 6-11 years capable of coordinating MDI actuation and inhalation
8. FEV1 greater than 60% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA and at least 12 hours for LABA
9. Reversible and variable airflow limitation: At least 12% increase of FEV1 15-20 min after inhalation of 200 µg salbutamol. Reversibility has to be demonstrated at Visit -1 or needs to be documented by valid spirometric results obtained within 6 months prior to Visit -1
10. Ability to read and write and to fill in the patient diary by the patient or by patient’s parent(s) or legal representative
11. Ability to handle correctly the peak flow meter and the metered-dose inhalers with/without spacer
At Visit 0:
1. FEV1 greater than 60% and less than 80% of the predicted value by the European Community for Coal and Steel (ECCS) after a washout period of at least 6 hours for RABA (reliever medication)
2. FEV1 within +/- 15% of the value obtained at Visit -1
3. At least 2 of the following criteria fulfilled during the last 7 days of the run-in period:
3.1. Nighttime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 1 day
3.2. Daytime symptom score (diary card rating of asthma symptoms) is at least 1 on at least 3 days
3.3. Use of RABA on at least 4 days
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
At V-1:
1. Intermittent or persistent mild or severe asthma as defined by GINA
2. Evidence of any active concomitant pulmonary disease other than asthma, i.e. chronic bronchitis
3. Respiratory tract infection (including sinusitis) and middle ear infection within 4 weeks prior to Visit -1
4. Acute asthma exacerbation within 4 weeks preceding Visit -1
5. Acute asthma exacerbation requiring hospitalization or emergency room visit within 12 weeks preceding Visit -1
6. History of life-threatening acute attacks or intubation for asthma
7. History of seasonal asthma exacerbation
8. History of paradoxical bronchospasm after inhaled asthma therapy
9. Active or inactive lung tuberculosis
10. Overdependence on RABA, i.e. frequency of RABA inhalation not consistent with persistent moderate asthma
11. Patients naive for inhaled corticosteroids
12. Change in asthma medication or regimen (other than inhalation of RABA) within 4 weeks preceding Visit -1
13. Administration of cromones within 4 weeks preceding Visit -1
14. Administration of oral corticosteroids within 4 weeks preceding Visit 1
15. More than 2 courses of oral corticosteroids within the last 12 weeks
16. Allergen-specific immunotherapy within the last 12 weeks
17. Long-acting antihistamines within 1 week preceding Visit -1 (astemizole within 12 weeks)
18. Use of beta-blockers or potent inhibitors of the cytochrome P450-3A4 system like ketoconazole, itraconazole, ritonavir within 4 weeks preceding Visit -1
19. Vaccination with live-attenuated virus within 2 weeks preceding
Visit -1
20. Impaired adrenal cortex function
21. Severe renal or hepatic disease
22. Hypokalemia uncorrected and/or serum potassium value on Visit -1 less than 3.5 mmol/L
23. Acute or history of severe cardiovascular disorders (e.g. heart rhythm abnormalities)
24. Untreated or unstable hypertension
25. Known diabetes
26. Hyperthyroidism not adequately controlled
37. Glaucoma
28. History of hypersensitivity to one or both of the active ingredients or to any other component of the preparations or reliever medication
29. Presence of any other severe decompensated concomitant disease (endocrine, hematological, neurological, immunological)
30. Known active and significant pulmonary abnormalities as detected on chest radiographs
31. Other relevant medical condition, ECG abnormality, or laboratory profile that might compromise the patient’s safety, compliance, or interfere with the evaluation or preclude completion as judged by the investigator or other contraindication to test drug.
32. Females of childbearing potential, not willing to abstain from sexual activities throughout complete duration of participation in the study
33. History of non-compliance with asthma management plan
34. Current participation in another investigational drug study, or participation in any clinical study involving an investigational drug within 3 months prior to Visit -1
35. Lack of sufficient co-operation or compliance or existing psychosocial problems
36. Legal incapacity of the patient’s parent(s) or legal representative or other circumstances rendering the patient’s parent(s) or legal representative unable to understand the nature, scope and possible consequences of the study
At V0:
1. Acute respiratory tract infection during run-in period
2. Severe asthma exacerbation during run-in period
3. Any intake of asthma medication other than the inhalation of the supplied reliever medication during run-in period
4. Use of more than 6 actuations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method